ECG-based cardiac screening programs: Legal, ethical, and logistical considerations

CONTEMPORARY REVIEW

ECG-based cardiac screening programs: Legal, ethical, and logistical considerations Jessica J. Orchard, MPH, BEc/LLB, GradDipLegPrac,*k Lis Neubeck, PhD, RN,† John W. Orchard, MBBS, PhD, MD,* Rajesh Puranik, MBBS, PhD,* Hariharan Raju, MBChB, PhD,‡ Ben Freedman, MBBS, PhD,*k Andre La Gerche, MBBS, PhD,x Christopher Semsarian, MBBS, PhD, MPH, FHRS*{ From the *Faculty of Medicine and Health, University of Sydney, Sydney, Australia, †School of Health and Social Care, Edinburgh Napier University, Edinburgh, United Kingdom, ‡Macquarie University, Sydney, Australia, xBaker Heart and Diabetes Institute, Melbourne, Australia, {Centenary Institute, Royal Prince Alfred Hospital, Sydney, Australia, and kHeart Research Institute, Charles Perkins Centre, Sydney, Australia. Screening asymptomatic people with a resting electrocardiogram (ECG) has been theorized to detect latent cardiovascular disease. However, resting ECG screening is not recommended for numerous populations, such as asymptomatic middle-aged (sedentary) people, as it is not sufficiently sensitive to detect coronary artery disease. While the issues raised in this article are largely common to all screening programs, this review focuses on 2 distinct programs: (1) screening elite athletes for conditions associated with sudden cardiac death (SCD); and (2) screening people aged 65 years for atrial fibrillation (AF). These 2 settings have recently gained attention for their promise and concerns regarding prevention of SCD and stroke, respectively. If screening is to be done, it must be done well. Organizations conducting screening must consider a range of legal, ethical, and logistical responsibilities that arise from the beginning to the end of the process. This includes consideration of who to screen, timing of screening, whether screening is mandatory, consent issues, and

Introduction Many electrocardiogram (ECG) screening programs exist internationally, usually with the key aim of using a resting ECG to screen asymptomatic people for potentially lifethreatening cardiac diseases (Table 1). These programs have been trialed in broad age groups: young athletes (including elite athletes), middle-aged people (both sedentary and athletes), and older people (often aged 65 years). The rationale for screening athletes is that intense exercise represents a trigger for cardiac arrhythmias, meaning athletes may Ms J.J. Orchard is supported by an Australian Government Research Training Program scholarship. Prof Semsarian is supported by an NHMRC Australia Practitioner Fellowship (#1154992). Profs J.W. Orchard, Puranik, La Gerche, Raju, and Semsarian have no disclosures. Profs Freedman and Neubeck: Pfizer/BMS, Boehringer-Ingelheim grants outside the submitted work. Prof Freedman: prior fees, advisory board honoraria from Bayer, BoehringerIngelheim, and Pfizer/BMS. Address reprint requests and correspondence: Prof Christopher Semsarian, Centenary Institute, Locked Bag 6, Newtown, NSW, 2042 Australia. E-mail address: [email protected].

1547-5271/$-see front matter © 2019 Heart Rhythm Society. All rights reserved.

auditing systems to ensure quality control. Good infrastructure for interpretation of ECG results according to expert guidelines and follow-up testing for abnormal screening results, including a pathway to treatment, are essential. Finally, there may be significant implications for those diagnosed with cardiac disease, including insurance, employment, the ability to play sport, and mental health issues. There are several legal risks, and the best protective measures are good communication systems, thorough clinical record-keeping, careful handling of eligibility questions for those diagnosed, and reference to expert guidelines as the standard of care. KEYWORDS Athletes; Atrial fibrillation; Ethical; Legal; Screening; Sudden death (Heart Rhythm 2019;16:1584–1591) © 2019 Heart Rhythm Society. All rights reserved.

be at greater risk of sudden cardiac death (SCD). Screening has also been investigated in older populations at risk for thromboembolic complications of atrial fibrillation (AF). The rationale is that oral anticoagulants (OACs) have demonstrated efficacy in preventing stroke in individuals with AF, even in people who are asymptomatic. The groups for which screening is recommended vary. The European Association of Preventive Cardiology (EAPC) recommends screening (including a resting ECG) asymptomatic middle-age/senior individuals engaging in high-intensity sport,1 which is not generally recommended by other experts.2,3 In Italy4 and Israel,5 ECG screening of all young athletes (of any level) is mandated, whereas in most other countries ECG screening of athletes is restricted to those at the elite level. We note that ECG screening in asymptomatic middle-aged sedentary people is not recommended by any leading bodies.2,3 While the issues raised are largely common to all screening programs, this review focuses on 2 distinct programs: (1) screening elite athletes for conditions associated with SCD; https://doi.org/10.1016/j.hrthm.2019.03.025

Orchard et al Table 1

Legal and Ethical Issues for ECG Cardiac Screening

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Resting ECG screening of asymptomatic individuals

Group

Screening Population

All young people

Cardiac conditions associated with SCD

Young elite athletes (age 16–35 y)

Groups/organizations in favor

Arguments against

Summary

Cardiac Risk in the Young  Expensive (CRY), UK  Large number of false Mandated by law for young positives athletes (broadly defined)  Lack of evidence in in Italy,4 Israel5 support

Not recommended in most countries

Vast majority of major  Expensive sporting organizations and  Need randomized trial guidelines: evidence of benefit  ESC30  AHA (history and physical examination, not ECG)11  International Olympic Committee  American Medical Society for Sports Medicine (AMSSM)9  Australasian College of Sport and Exercise Physicians (ACSEP)58  FIFA  World Rugby

Consider if sufficient infrastructure available to support program

Some clinics

 Cannot detect coronary Not recommended2,3 artery disease in absence of previous infarction  Generally low-risk group for AF

Middle-age sedentary people (age 35–64 y)

Acquired cardiac disease, arrhythmias

Middle-age/senior people engaging in physical activity

Acquired cardiac disease, arrhythmias

Consider for higher-risk  EAPC,1 based on self Individual risk individuals assessment may be assessment of individual’s undertaking intense inaccurate cardiac risk and the exercise  Cannot detect coronary intensity of exercise artery disease in absence of prior infarction

Elderly (age 65 y)

AF

Many guidelines recommend  Insufficient evidence of AF screening, including use of reduction of risk of a single-lead ECG: screen-detected AF  ESC17  AF-SCREEN16  Heart Foundation of Australia18  European Heart Rhythm Association (EHRA), Heart Rhythm Society (HRS) et al19

Consider if sufficient infrastructure available to support program

AF 5 atrial fibrillation; AHA 5 American Heart Association; EAPC 5 European Association of Preventive Cardiology; ECG 5 electrocardiogram; ESC 5 European Society of Cardiology; FIFA 5 Fédération Internationale de Football Association; SCD 5 sudden cardiac death.

and (2) screening for AF in people aged 65 years. These programs were selected as they represent 2 of the largest, and increasingly common, cardiac screening programs. As with all discussions on screening, these issues relate to testing asymptomatic people. Those with suspicious symptoms and/ or significant family history should seek specialist advice.6

Rationale for screening elite athletes SCD is a tragic outcome for athletes and their families. Although relatively rare, SCD is the leading cause of death

for people playing sport.7 In the United States, .90 young athletes die suddenly each year (about 2 per 100,000 athletes per year).7 This rate is 2.5-fold higher than that of the agematched nonathlete population.8 The risk of SCD, or sudden cardiac arrest (SCA/D), varies according to age, gender, ethnicity, sport, and competitive level.9 In Australia, SCD in the young (age 1–35 years) occurs in 1.3 per 100,000 people per year, and approximately 15% occur either during exercise (11%) or immediately after exercise (4%).10 Competitive sport may be a significant risk factor for young

1586 people with genetic heart diseases, such as hypertrophic cardiomyopathy (HCM), arrhythmogenic cardiomyopathy, familial long QT syndrome, and catecholaminergic polymorphic ventricular tachycardia, which can lead to SCD without the athlete having any symptoms beforehand. There is strong debate about whether screening programs are worthwhile in terms of preventing SCD in young people.11 Data from Italy, where cardiac screening of athletes is mandated by law, is often cited as persuasive evidence in favor of screening. A study that compared the incidence of SCD in the years before and during screening showed a 90% reduction in the screened population.4 However, this success has not been mirrored in Israel nor in various US programs.12 A detailed review by the American Medical Society for Sports Medicine suggests the decision about screening should depend on the baseline risk of SCD in the relevant population and the availability of required cardiology resources and infrastructure to properly conduct such a program.9 Many major organizations and sports governing bodies now recommend cardiac screening of athletes. For many, there is a “strong pragmatic argument” to screen as “a well-resourced professional organisation [has] a perceived need to.have taken every possible step to reduce this risk.”6 For professional athletes who are employees, there is also a work, health, and safety argument in favor of screening as athletes are required to push their bodies in the course of employment, and any cardiac abnormalities that raise the risk of SCD should be identified as vigorous exercise can be a trigger. There is substantial cost in running a screening program, with one model estimating a 20-year screening program of young US athletes would cost US$10 million per life saved.13 In the United Kingdom, the Football Association (FA) reported a cost of US$342 per athlete for initial screening (including ECG and echocardiogram) and US$102,782 per case of disease associated with SCD.14 Another UK program reported a cost of US$87 per athlete screened (including ECG and follow-up costs).15

Rationale for AF screening AF is the most common cardiac arrhythmia, and the prevalence rises steeply with age.16 According to estimates, 25% of middle-aged adults in Europe and the United States will develop AF in their lifetime.17 About 1.4% of the population aged 65 years have undiagnosed AF, which commonly is asymptomatic.16 Left untreated, AF results in an up to 5fold increased risk of stroke.16 Numerous guidelines and expert consensus statements now recommend screening for AF in people aged 65 years.16–19 Data are lacking on the outcomes of AF screening (eg, reduction of stroke), and guidelines are based on the premise that the prognosis of screen-detected AF is similar to that of AF detected incidentally and will respond similarly to OAC.20 Most guidelines recommend opportunistic screening by pulse palpation or single-lead ECG. For those at high risk for stroke (CHA2DS2-VASc score 2 in males or 3 in females), treatment with OAC can reduce stroke risk by 64% compared to control.17,21 Economic

Heart Rhythm, Vol 16, No 10, October 2019 assessments have generally found AF screening programs to be cost-effective.16

Key issues in cardiac screening Once an organization has decided to conduct a screening program, there are ensuing legal, ethical, and logistical considerations. The primary point is that if screening is to be done, it must be done well.22,23 Several articles helpfully contribute to these issues,24–27 but most emphasize the doctor’s role (rather than the organization’s role) and focus on the end part of the process: treating individuals who have been diagnosed and/or preventing litigation. These aspects are important but relate to a minority of patients and a small part of the process. There are many legal, ethical, and logistical issues involved in designing and running an ECG screening program, from the beginning to the end of the process (Figure 1).

Eligibility The first question is, “Who is eligible for screening?” A key ethical issue with screening is that the condition, if found, must be serious enough to outweigh the negatives of screening (time, false positives, etc). Ideally, screening should be offered to sufficiently at-risk people. According to Bayes’ theorem, the chance of a positive being a true positive is proportional to the baseline incidence in the population being screened. In sport, some groups are much higher risk. For example, the annual risk for SCD in African/Afro-Caribbean (“black”) male basketball players is 1 in 4400.28 Conversely, black athletes have demonstrably higher proportions of pathological ECG abnormalities, confounding interpretation. Athlete screening often commences at 16 years, given that ECG variability in those younger than this age is more common—the “juvenile ECG pattern.”29 Arguably, athlete screening should be done early enough that the person has flexibility to choose another career if a serious cardiac condition is detected. For AF, most guidelines use an age cutoff.17,18

Method of screening and frequency Another important consideration is the method and frequency of screening, with a focus on compliance. Considerations include whether an opt-in or opt-out model works best, and/or whether systematic or opportunistic screening is more appropriate. When screening athletes, it is important to consider whether an opt-in or opt-out model is preferable. Opt-out may produce a higher rate of compliance, although athletes should be given sufficient opportunity to make an informed decision about whether to participate. However, whether a program should be mandatory may be less important than developing a “best practice” program: something that varies according to the population and the resources available.23 There has been debate about whether an ECG is required for athlete screening. Although the European Society of Cardiology (ESC) recommends an ECG,30 the American Heart

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Figure 1

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Timeline of issues related to ECG screening. ECG 5 electrocardiogram; SCA 5 sudden cardiac arrest.

Association recommends a history and physical examination but not ECG.11 Evidence now suggests an ECG substantially improves the sensitivity and specificity of screening compared with a clinical examination alone.6,14 There are no clear recommendations for frequency of screening. It appears that a single screen at age 16 years may not be sufficient,14 and that screening every 2 years (age , 21 years) and every 5 years thereafter may be more appropriate. This approach has recently been adopted by the FA.31 Refinements to athlete ECG interpretation criteria (the Seattle criteria32 and now the International criteria29) have substantially improved diagnostic yield. Most AF screening guidelines now recommending opportunistic, rather than systematic, screening.20 As we have previously argued, the focus should be more on screening a higher proportion of the at-risk population in order to increase the effectiveness of stroke prevention.20 In terms of frequency, most guidelines recommend single time-point screening as opposed to continuous ECG monitoring over a longer period, which may detect “brief episodes of AF of questionable clinical significance.”20 As we have noted, this will present challenges with the rise of wearable technology, such as smartwatches with AF-detection algorithms and ECG capability (Apple Watch Series 4), often worn by younger people at lower risk of stroke.20 Evidence is lacking as to the ideal frequency, but current suggestions are for annual screening.16

Timing Screening is often performed as an adjunct task, at a time that suits the doctor/practice or sporting organization. However,

practices/organizations must be aware of the potential implications and ensure there is time to obtain informed consent and to organize follow-up if required, taking into account the person’s work, travel, or playing commitments. The best model would vary according to circumstances, but in general it is preferable to give people advance notice and to screen athletes in the off-season or, in our opinion, at least 10 working days before competing to ensure there is sufficient time to complete follow-up if required.

Consent issues In general, patients must give informed consent before undergoing screening. This requires an understanding of the benefits and harms33; the accuracy of the test; the risks; and the implications of an abnormal result.34 Patient information materials often overemphasize the benefits and underplay the harms and uncertainties.35 Issues of capacity may arise with younger or elderly people, who may be considered vulnerable populations. Children aged ,18 years can be vulnerable due to a lack of capacity to make decisions and power inequalities with adults.36 Older patients can be vulnerable, especially those with multiple chronic conditions.37 These issues must be considered carefully to ensure the person is capable of understanding the process and implications of screening. People ,18 years who are considered “mature minors” may have capacity to consent to screening, although for younger people (eg, aged 15 years), it may be prudent to obtain parental consent. Similar considerations may apply to elderly people (eg, those with dementia).

1588 Second, the issue of consenting to “half a screen” can be problematic. This occurs when a person consents to the initial test but refuses (either overtly or covertly) follow-up as recommended. Importantly, there must be a system to identify those who have not completed required follow-up and a policy for what to do in this scenario. Defining what is a reasonable level of follow-up depends on the circumstances, but should be well documented. Completing the screening process can be more easily mandated for athletes who are employees and for elderly people who are regular patients of a practice.

Communication of results and pathway to treatment All results must be reviewed, filed, communicated, and followed-up if required. ECG review must be completed by someone with relevant expertise. Athlete ECGs must be reviewed by someone with specific expertise in best-practice interpretation guidelines29 to reduce false positives. For AF, many single-lead devices have an automated algorithm for interpretation, but those with a diagnosis of “possible AF” must be verified, and those with an “unclassified” diagnosis must also be reviewed. All 12-lead ECG automated diagnoses require review. Other workup, including a review of the CHA2DS2-VASc stroke risk scores and discussion of the benefits and risks of treatment, should be done in accordance with guidelines.17 A well-established pathway to follow-up testing and treatment for anyone with a verified abnormal test result is crucial.16 In a sports setting, the required infrastructure for screening includes sufficient cardiology resources to ensure ECGs are interpreted by someone with relevant expertise and that abnormal screening results are followed-up.9 The pathway to treatment should include consideration of logistics, whether playing/training can continue before the test is complete, and cover players who are visiting temporarily. In Izidor v Knight, a college basketball player was screened and ultimately diagnosed with HCM.38 However, the clearance form was signed before the follow-up testing and diagnosis were complete. The athlete continued to play but died of SCD 6 weeks later. This case shows the importance of adhering to the screening policy and completing testing before providing clearance. Communication and filing are crucial. Suboptimal communication between patients and doctors is a major risk factor for negligence cases and therefore a key area for prevention.39 An abnormal result that is not read and/or followed-up is risky. Even the best system will miss things occasionally, but this must be minimized.

Abnormal screening results and follow-up A substantial number of people will require follow-up tests, and the person conducting screening must be prepared to counsel patients with an abnormal result. Approximately 5% of athletes screened will require extra testing.40 Due to electrical and structural changes in the heart resulting from high-level training, athlete ECG interpretation guidelines have been continuously

Heart Rhythm, Vol 16, No 10, October 2019 refined and improved,40 with the International criteria (2017) now the gold standard.29 This has substantially reduced false positives, with one study showing the proportion of abnormal ECGs falling from 21.8% (2010 ESC recommendations) to 4.3% (Refined criteria).15 Ultimately, 0.3% of athletes in this study were diagnosed with a serious cardiac condition, and all of these ECGs were abnormal irrespective of the interpretation criteria used.15 A reduced false-positive rate decreases screening cost15 and improves identification of pathology.40 Anxiety is a key harm and can be reduced with timely communication and completion of follow-up tests.20,41 Interestingly, a study of screening in US college athletes found ECG screening did not cause undue anxiety for the majority (including those with false-positive results).41 For AF, approximately 14% of patients screened with a single-lead ECG have an abnormal result (eg, an automated result of possible AF or “unclassified”).42 “Unclassified” results may be caused by conditions such as sinus tachycardia/ bradycardia, left or right bundle branch block, or multiple ectopic beats. Additional testing should include echocardiography.17 Potentially unnecessary additional testing may result from an AF diagnosis and is a significant concern of the US Preventive Services Task Force.43 Importantly, there may be cases of “false reassurance” as even the best program will miss some cases.14 For athletes, only 60% of the conditions associated with SCD are visible on ECG.44 The dynamic nature of electrical cardiac problems means they can be missed; for example, a single time-point screen may miss paroxysmal AF, leading to intermittent ECG protocols.16 Thus, people undergoing screening must be informed of these limitations and encouraged to report any symptoms in the future.

Cardiac emergency response The importance of having a documented and well-practised action plan in place for cardiac emergencies, ideally including access to automated external defibrillators, cannot be overstated.9 Early recognition of SCA or stroke is crucial, and training relevant staff to identify symptoms can provide benefits well beyond the screened cohort. In sport, any nontraumatic collapse should be treated as cardiac until proven otherwise. For the elderly, educating practice staff, doctors, and patients to be aware of stroke symptoms is key to promoting early access to treatment.

Program evaluation All screening programs should be evaluated regularly to assess their efficacy, benefits, and harms. Reviews should consider any new scientific evidence that should be reflected in the program and/or current care and ideally should include updates on education on cardiac emergency response (eg, resuscitation and stroke recognition).

Issues for those diagnosed with a cardiac condition For those diagnosed with a cardiac condition, there may be important implications for insurance, work, sports, and

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mental health. As with all medicolegal issues, insurance rules vary by jurisdiction. Once diagnosed, any preexisting heart condition can have implications for acquiring new insurance (eg, travel, health, life insurance). Premiums may be higher, exclusions added, or cover refused. Some jurisdictions have protections for certain types of insurance. For example, Australian private health insurance is community rated [Private Health Insurance Act 2007(Cth)], meaning everyone pays the same premium for the same product regardless of their health status or claims history. Genetic testing is important, especially for young people diagnosed before they have life insurance. In general, when applying for insurance, a person must disclose relevant health information, including genetic tests. Some jurisdictions offer little protection. For example, in Australia, life insurers can use genetic test results to raise premiums, impose conditions, or refuse insurance altogether if based on actuarial or statistical data [s46 Disability Discrimination Act 1992(Cth)] and can even ask whether an applicant is considering or awaiting results,45 but cannot ask an applicant to have a genetic test. Other jurisdictions, including the United Kingdom, Canada, and many European countries, have banned insurers from using genetic test results.46 Issues may arise regarding employment and driving. In the United Kingdom, AF is a notifiable condition and may prevent a person from driving a bus/lorry.47 Many countries regulate the use of genetic tests in employment; however, it is unclear how this would apply to an athlete who is an employee (especially if disqualification is recommended and/or for an athlete who is, for example, genotypepositive/phenotype-negative for HCM).24 Importantly, there are substantial psychological implications for athletes disqualified from sport. As documented by Asif et al,48 these athletes may experience significant psychological distress and should be monitored and offered support.

Eligibility and disqualification from sport A central issue for those diagnosed with a serious cardiac condition is eligibility to play sport. Historically, a paternalistic approach was favored, with athletes “disqualified” from competitive sport. Although the ESC guidelines (2005)49 remain generally more restrictive, a more permissive approach with a “shared decision-making model” is included in the American College of Cardiology guidelines (2015).50 The American College of Cardiology guidelines are more recent and take into account research developments in risk stratification. However, many areas require further research, and most guidelines are mainly based on expert consensus.27 Similarly, a model of “empowerment” has been proposed, which allows athletes to choose the extent to which they participate in the eligibility decision.27 The ethical implications of disqualification, particularly with screen-detected conditions in asymptomatic athletes, have been discussed comprehensively in a review that proposes an individualized approach with “collaborative decision-making.”24

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Realistically, the physician’s risk profile is as important as the athlete’s. Legal and ethical responsibility is fundamental, and doctors are less likely to “forbid” participation if they are unlikely to be blamed or be liable. One option for sports is to have a group of experts assist with decisions (with the player’s consent), as in the FA.14 There is also a question of what amount of cardiac risk an athlete can consent to in an organized setting, especially for minors. Where the athlete is an employee, general work, health, and safety obligations also apply to the employer. Sporting organizations also face substantial reputational (and other) risk if an athlete suffers SCA/D on television.

Litigation risks Litigation is highly stressful and public, even for people/organizations ultimately vindicated. Laws are specific to each jurisdiction, but the general legal duty is to provide the best medical care available based on the current state of scientific knowledge.22 The standard of care is often established by asking what the hypothetical “reasonable” physician, exercising due care and skill, would have done in those circumstances. Expert guidelines may be persuasive evidence of the standard of care.51 The importance of having thorough, contemporaneous clinical notes, documenting any restrictions on activity, cannot be overstated.51 Specific areas of risk include the following: Poor communication: Good communication may not be sufficient to prevent all litigation but is a strong protective measure. Detecting disease but not treating it: If a condition is detected, a treatment decision must be made in a timely fashion. If an untreated AF patient suffers a stroke, it may constitute a breach of duty as stroke may be a reasonably foreseeable outcome.52 One legal website specifically advertises services for AF patients who may have experienced negligence in OAC prescription.53 Clearing a person with disease is an obvious risk. ECGs and any follow-up tests must be completed and interpreted with due care and skill.26 To the extent possible, guidelines should be followed.54 Exclusion from sport: Guidelines are not consistent, but generally exclusion decisions need to be reasonable, well explained, and based on a thorough scientific process.55 There are several US cases in which players sued unsuccessfully to challenge exclusion from sport. In Larkin v Archdiocese of Cincinnati, the Court held a football player with HCM could be excluded from competing, even though he was willing to sign a waiver.56 Team physicians have a complex “dual loyalty” between the athlete and the team’s needs.54 Ideally, decisions about eligibility should be made by an expert panel (with the player’s consent) and/or should follow guidelines. Waivers: Beware. Courts often question waivers, which do not remove the doctor’s legal obligation to conform to applicable standards of good medical practice.25,51 Waivers between an adult professional athlete and a team physician may be enforceable, particularly when another specialist

1590 has cleared the player,51 but this raises a “red flag” and potential “doctor shopping” to obtain the desired opinion.26 Any major adverse event. Any major adverse event, such as a stroke or SCA/D, especially one that occurs in public and/or if it appears preventable, represents a major risk. Good documentation and notes, including informed consent and discussion of the risks of noncompliance with treatment or activity restrictions, are important.25 In Gathers v Loyola-Marymount University, a basketball player was prescribed a beta-blocker for ventricular tachycardia, but his dose was reduced to improve performance.57 Shortly afterward, he suffered a SCD that was witnessed on television. His family sued the doctor and university for US$32.5 million, although the case settled.

Conclusion Many organizations, such as general practices and sports, are now conducting cardiac screening programs using a resting ECG. Any screening program involves some potential disadvantages, including anxiety, time, additional testing, and cost. Screening is often performed as an adjunct task and therefore, very good systems are needed for communication, filing, and ensuring a pathway to treatment. If screening of asymptomatic people is to be performed, it must be done well. Once an organization has committed to screening, there are a range of legal, ethical, and logistical responsibilities that must be addressed. This includes consideration of who to screen, the timing and frequency of screening, whether screening is mandatory, auditing systems, and consent issues. Systems for communicating results and facilitating follow-up testing for abnormal results, including a pathway to treatment, are essential. Finally, there may be significant implications for those diagnosed with cardiac disease, including insurance, employment, mental health, and the ability to play sport. There are several legal risks, and the best protective measures physicians can take are to communicate well, keep thorough clinical records, potentially to involve a group of experts in eligibility questions, and to follow expert guidelines as the standard of care.

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